FDA 510(k)

凱瑞

K 號：K251111 · 2025-05-07

決定日期2025-05-07

產品代碼JCX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Cary is the device name listed in this FDA 510(k) record. The listed applicant is Excitus AS. It received FDA 510(k) clearance on 2025-05-07 under 510(k) number K251111. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cary?

Cary is a medical device that received FDA 510(k) clearance on 2025-05-07. The listed applicant is Excitus AS. The 510(k) number is K251111.

When did Cary receive FDA 510(k) clearance?

Cary received FDA 510(k) clearance on 2025-05-07, under 510(k) number K251111.

Who is the listed applicant for Cary?

The FDA 510(k) record lists Excitus AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cary?

The FDA product code for Cary is JCX.

相關器械（代碼：JCX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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